Sr. Regulatory Affairs Specialist

Sr Associate, Regulatory Affairs Sr Associate, Regulatory Affairs sought by Karyopharm Therapeutics, Inc., a commercial-stage pharma co in Newton, MA: Manage reg submissions, publish and prep submission docs, proficiency with eCTD tools and processes, track regulatory filings, etc. Telecommuting acc

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Lake Forest, CA.Title: Regulatory Affairs Specialist - ContractorPay Rate: $58.79/hr (W-2)Job Description:- Compile and maintain regulatory documentation databases or systems.-...

About the RoleCollabera is seeking a skilled Regulatory Affairs Specialist II to join our team. As a key member of our Infectious Disease business unit, you will play a crucial role in preparing documentation for EU Technical Files and international product registrations.

Top 3-5 skills, experience or education required1. Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.3. Detail-oriented with the ability to proofread and check documents for accuracy and consistency.Purpose Statement:The Regulatory Affairs Specialist supports the development...

Regulatory Affairs Specialist II Location: Irvine, CA (Hybrid 3 days on site)12 month AssignmentPay Rate: $45-$49/hr.On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE...

Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...

JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned...

We are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This On-site role reports directly to the CEO. The Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory...

At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

Regulatory Affairs CoordinatorCity: FriscoState: TexasZip: 75034CornerStone Professional Placement has partnered with a reputable medical device manufacturing client seeking a Regulatory Affairs Coordinator. As the Regulatory Affairs Coordinator, you will be responsible for assisting the Regulatory Affairs team with gathering and organizing documents for...

Regulatory Affairs Associate Job DescriptionAt BioFire Diagnostics, we are seeking a highly skilled Regulatory Affairs Associate to join our team. As a Regulatory Affairs Associate, you will play a critical role in ensuring compliance with regulatory requirements and supporting the development of regulatory submissions.Key Responsibilities:Organize, update,...

Overview of the Role:The Senior Regulatory Specialist provides comprehensive regulatory expertise, supporting daily departmental operations and collaborating with the Manager of Regulatory Affairs to manage global medical device registrations. This role involves ensuring the department’s compliance with regulatory policies and managing both electronic and...

Regulatory Affairs AssociateLocation: Fremont, CAOur innovative client is seeking a Regulatory Affairs Associate to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and...

Job SummaryAlcon is seeking a highly skilled Digital Health Quality and Regulatory Affairs Director to lead our Quality and Regulatory Affairs team responsible for the development and maintenance of Alcon Digital Health products. The ideal candidate will have a strong background in quality and regulatory affairs, with experience in digital health products...

Yoh is seeking a Regulatory Affairs Specialist for our Pharmaceutical client here in St. Louis, Missouri. Join a growing team! Position Type: Contract (Hybrid) Rate: $30-$34/hr Hours: 8:00 am - 5:00 pm Position Summary:Plan/author/compile drug product dossiers in CTD format for expansion to international marketsPlan/author/compile/submit/manage variations...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway,...

Our partner specializes in their patented resources and ingredients, servicing the community with their profound discoveries globally in the biopharma space. They are in search of a Regulatory Affairs Specialist to play an exciting role across their innovative processes in LA!Schedule: Mon-Fri -8am-5pm (Hybrid)Salary: $85k - $100kDirect Hire...

Director, Regulatory Affairs CMC Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...

Director, Regulatory Affairs CMC - Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...